News Digest 11.04.2025 — 18.04.2025
Regulators
Artificial intelligence in Russian medicine awaits strict regulation
A specialized working group has developed a draft legislative regulation of artificial intelligence (AI) in Russia, RBK writes. The explanatory note to the document notes that it was developed to implement the National Strategy for the Development of AI until 2030 (approved in February 2024).
It is proposed to introduce a classification of AI systems by the level of potential risk. For systems with a high level of risk (used, among other things, in healthcare), mandatory state registration and certification may be introduced; for those with a limited level of risk, internal quality control systems and voluntary certification.
In addition, it is proposed to introduce liability for causing harm to life and health for those involved in the development and operation of artificial intelligence systems.
In April, the Federal Compulsory Medical Insurance Fund for the first time disclosed the amount of expenses for paying for diagnostics using artificial intelligence technologies. In 2024, medical institutions performed more than 1.17 million mammographic examinations using computer vision for 359 million rubles.
At the end of last year, the Ministry of Health launched a federal incident related to the introduction of medical devices with artificial intelligence (MD with AI) into practical healthcare. Its goal was to introduce at least three medical devices with AI in each region. Regions were advised to rely on Moscow's experience, but not all of them successfully coped with this task.
In Russia, 38 medical devices with AI have already been registered, which are used as systems for supporting medical decision-making based on the results of radiological images, video streams during endoscopic procedures and other studies, and more than 200 solutions are in the process of being created in organizations subordinate to the Ministry of Health of Russia. The TOP3 nosologies include oncology, therapy, obstetrics/gynecology. At the end of March, the Interdepartmental Working Group under the Ministry of Health of Russia approved the Code of Ethics for the Use of AI in Healthcare. The document consists of four chapters and covers various issues, including the need to ensure data confidentiality and comprehensive control over the system.
Market news
Spare parts for "heavy" medical equipment may be exempted from sanctions
The head of the American Chamber of Commerce in Russia (AmCham) Robert Agee intends to include in the white paper for the US authorities recommendations on lifting sanctions on the supply to Russia of components, consumables and spare parts for medical equipment that are dual-use.
A significant part of the parts of medical equipment falls under the category of dual-use goods, as a result of which foreign companies have to prove to regulatory authorities that the products they supply will be used only for medical purposes.
Earlier, AmCham managed to get the US authorities to partially lift restrictions on the supply of medical equipment to Russia. In May 2023, the US Department of Commerce introduced export controls on medical equipment and medical products shipped to Russia and Belarus, requiring a permit to ship them.
Almost a year later, on April 25, 2024, the US lifted export restrictions on a number of medical equipment. The MED license exception for export to Russia and Belarus became available for medical products listed as EAR99, which corresponds to consumer goods that do not require high-tech production.
Source: https://t.me/vademecum_live/17676
Collusion in state procurement of medical products uncovered in Udmurtia
The Udmurt Republic's Federal Antimonopoly Service has uncovered an anticompetitive agreement between the regional Ministry of Health, Zdorovye LLC, Viasta LLC, and Vitaline LLC. According to the FAS materials, as a result of the collusion, the companies received advantages in 179 tenders and concluded government contracts for the supply of medical equipment and medical products for the needs of the ministry and clinics subordinate to it for a total of 498.3 million rubles.
The name of the representative of the Udmurt Ministry of Health is not disclosed in the FAS document, but it is indicated that from 2022 to 2023, the acting minister, who also previously headed the Republican Medical College, communicated with the owners of the companies. This information coincides with the facts from the biography of Natalya Yakimova, who was sentenced to one year in prison for abuse of office in November 2024.
Source: https://t.me/vademecum_live/17693
Other
A Russian company presented unique software for bionic hand prostheses
MeHandA is the only hand with a touch panel for switching grips (active actions). It allows you to change them on the prosthesis itself. For example, a person with a double amputation can simply swipe the touchscreen over any surface, even clothing, to switch to the desired grip. You can also switch between grips and gestures using muscle triggers and the on/off button. switches.
The grip generator itself is one of the unique developments of MaxBionic, which no one has yet been able to replicate. The generator allows you to create an individual grip using muscle signals. At the same time, the speed of finger movement and grip switching exceeds the capabilities of all domestic and foreign similar brushes.
The MeHandA brush also has a tactile sprayed little finger, which allows you to use gadgets. In case of a paired amputation, it is irreplaceable. Usually, a person uses the index finger to work with a gadget. But to do this with a prosthesis, you must first turn on a certain trigger, then turn the brush, turn it with the palm inward, make a certain grip with the index finger and only then swipe the finger across the screen. This is long. In addition, many manufacturers have a fixed wrist, and many brushes do not have flexion. The little finger with the Touch Screen function allows you not to change the position of the screen.
New registered medical devices
We publish a list of new medical devices registered from 04/11/2025 to 04/18/2025
Link to the list: [see. table in attachment]
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